FDA.reportPublic FDA data

ClearView 3

Primary DI
00844369038232
Brand
ClearView 3
Company
Lenstec Barbados Inc
Model
SBL-3+18.25
Catalog number
SBL-3
Device description
Multifocal IOL modified plate, HEMA
Published
2023-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MFKLens, Multifocal Intraocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200020000SBL-3 Multifocal Intraocular LensLenstec, Inc.2022-07-22MFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844369038232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844369038232008443690382328443690382320844369038232

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18665367832feedback@lenstec.com

Regulatory Flags#

DUNS number
860235001
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844369016858I9011S05-21352024-05-06
00844369016865I901205-2136-B2024-05-06
00844369016872I9012FS05-2138-B2024-05-06
00844369018944LC16LC162024-05-06
00844369018968LC24LC242024-05-06
00844369018975CART45SCART45S2024-05-06
00844369018982CARTMCARTM2024-05-06
00844369038003ClearView 3SBL-3+10.0SBL-32023-01-25
00844369038010ClearView 3SBL-3+10.5SBL-32023-01-25
00844369038027ClearView 3SBL-3+11.0SBL-32023-01-25
00844369038034ClearView 3SBL-3+11.5SBL-32023-01-25
00844369038041ClearView 3SBL-3+12.0SBL-32023-01-25
00844369038058ClearView 3SBL-3+12.5SBL-32023-01-25
00844369038065ClearView 3SBL-3+13.0SBL-32023-01-25
00844369038072ClearView 3SBL-3+13.5SBL-32023-01-25
00844369038089ClearView 3SBL-3+14.0SBL-32023-01-25
00844369038096ClearView 3SBL-3+14.5SBL-32023-01-25
00844369038102ClearView 3SBL-3+15.0SBL-32023-01-25
00844369038119ClearView 3SBL-3+15.25SBL-32023-01-25
00844369038126ClearView 3SBL-3+15.5SBL-32023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844369038003ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038010ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038027ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038034ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038041ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038058ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038065ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038072ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038089ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038096ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038102ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038119ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038126ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038133ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038140ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038157ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038164ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038171ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038188ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038195ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038201ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038218ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038225ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038249ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038256ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038263ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038270ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038287ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038294ClearView 3Lenstec Barbados IncMFK2023-01-25
00844369038300ClearView 3Lenstec Barbados IncMFK2023-01-25